Job Description

Specialist Quality Assurance

The candidate must be based in Madrid (Spain)

Purpose of the role

The Quality Department has the responsibility for managing key elements of the local GDP/GMP Quality Management System (QMS) and monitoring its effectiveness. The department must ensure that both regulatory (EU + Local) and internal requirements are always met for products marketed by Organon. The department is also the Primary contact during regulatory inspections.

The aim of the role is to provide direct support to the Department Lead by conducting the day-to-day quality activities of the Quality Department in Spain and Portugal required by Good Distribution Practices (GDP) as well as by Corporate Policies. The scope of application includes activities related to good distribution practices as well as MAH responsibilities.

Main responsibilities

The foreseen task includes but are not limited to:

• Management of local procedures and training
• Deviation management and monitoring, CAPA, change control and risk assessment
• Preparation and/or review documentation for new batches and return management
• Management of complaints, incidents and quality queries related to product stability
• Participating in market recalls and mock recalls.
• Monitor and document product destruction
• Self-Inspection planning, execution and documentation
• Support the customer qualification requests and the periodic verification
• Handling of temperature excursions and other logistic events during transport, warehousing and distribution
• Participating in quality oversight of the local 3PL. Support the business with Organon partners pertaining to the compliance of 3PL operations according to Organon guidelines.
• Support notification of product shortages to Health Authorities and related communications
• Preparation of local and Cluster Quality team meetings
• Support in the preparation, performance and follow-up activities related to internal and/or external audits as well as to inspections by the Health Authorities
• Preparation of KPI
• Support in the further development of local QMS and in the implementation of new regulations and Organon global quality system
• Participate in Quality based projects working as part of a multidisciplinary team as required

Your profile

• Degree in Health Sciences. Training in the Pharmaceutical Industry (areas of Quality/Regulatory Affairs) will be valued.
• Member of the Spanish Pharmaceutical Society (desirable)
• 1-2 years’ experience in Quality (GMP/GDP) within Pharma industry
• Knowledge of EU quality related regulations for medicines and medical devices
• High knowledge of English (oral and written). Portuguese desirable.
• Knowledge of computer applications (e.g. Microsoft Office)
• Organizational, analytical and conceptual thinking skills, information management, structured and methodical person, good capacity for dialogue and personal relationships, high motivation and learning capacity
• Proactivity, communication and teamwork skills, eager to learn and take on challenges, with internal and external customer orientation, initiative and flexibility
• Has Ethics and Integrity, results driven, foster collaboration
• Workplace in Madrid

What we offer

We welcome you to a truly global, dynamic, and challenging environment with excellent personal development opportunities. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary
• Attractive collective health care and insurance packages
• Solid Pension Plan company paid
• Annual bonus based on company performance
• Flexible benefits
• Numerous training, coaching, and e-learning modules for long-term job opportunities and development

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. We have a current local Equity Plan that ensures equal treatment and opportunities for all our employees and candidates.

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R535556